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Bioavailability Study of Midazolam Administered as a Solution by Conventional Syringe or ZENEO®

NCT05026567 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-07-22

No results posted yet for this study

Summary

Primary objective of this study is to describe the plasma pharmacokinetics of midazolam after single intramuscular injection on bare skin in the thigh by the needle-free injector Zeneo® compared to injection on bare skin in the thigh by a conventional syringe (Reference) in terms of relative bioavailability and bioequivalence.

Conditions

  • Healthy

Interventions

DRUG

2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL)

Intramuscular injection

COMBINATION_PRODUCT

ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thigh

Intramuscular injection

COMBINATION_PRODUCT

ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal area

Intramuscular injection

COMBINATION_PRODUCT

ZENEO® Midazolam (10 mg / 0.625 mL) through clothing in thigh

Intramuscular injection

Sponsors & Collaborators

  • Crossject

    lead INDUSTRY

Principal Investigators

  • EFW Krantz, PhD · Farmovs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2022-07-14
Completion
2022-07-15

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05026567 on ClinicalTrials.gov